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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 April 2013
Main ID:  RBR-2k3kbq
Date of registration: 07/03/2012
Primary sponsor: Escola de Enfermagem Universidade Federal de Minas Gerais - Belo Horizonte, MG, Brazil
Public title: Comparison of the effectiveness of the use of pads in adult patients admitted to the Intensive Care Unit
Scientific title: Comparison of the effectiveness of the use of pads in adult patients with diagnoses of hyperthermia admitted to the Intensive Care Unit
Date of first enrolment: 01/03/2012
Target sample size: 27
Recruitment status: not yet recruiting
URL:  http://www.ensaiosclinicos.gov.br/rg/RBR-2k3kbq/
Study type: 
Study design:  Clinical trial, blind, randomized, controlled, with three arms.  
Countries of recruitment
Brazil
Contacts
Name: Tânia  Chianca
Address:  Avenida Alfredo Balena, 190 30130100 Belo Horizonte Brazil
Telephone: (31)34099887
Email: taniachianca@gmail.com
Affiliation:  Escola de Enfermagem Universidade Federal de Minas Gerais
Name: Patrícia  Salgado
Address:  Rua Carlos Sá, 641, cs 1 31550200 Belo Horizonte Brazil
Telephone: (31)87118591
Email: patriciaoliveirasalgado@gmail.com
Affiliation:  Hospital Municipal Odilon Behrens
Key inclusion & exclusion criteria
Inclusion criteria: For inclusion of patients in this study will be established the following criteria:
be over 18 years;
body temperature 38.3 ° C;
to consent to participate in the survey or have authorized their participation by signing the Statement of responsibility Consent

Exclusion criteria: Exclusion criteria are:
patient or guardian does not agree to sign the Instrument of Consent;
patients with severe heart disease, traumatic brain injury, malignant hyperthermia, pregnant women, which has a history of adverse reactions following the use of physical methods (hot or cold) in the reduction of body temperature and do not tolerate treatment.


Age minimum: 18
Age maximum: 105
Gender: -
Health Condition(s) or Problem(s) studied
Fever, infection
C23.888.119.344
Intervention(s)
Intervention Group I - Apply warm compress associated with administration of antipyretic. The bandage is soaked in water temperature between 29 and 30 ° C,and remain in the patient for 20 minutes.

Intervention Group II - consisting of patients who apply cold compress associated with administration of antipyretic. The bandage is soaked in ice water, and remain in the patient for 20 minutes.

Control Group - comprised of patients who receive only the administration of antipyretic to reduce body temperature.

The body temperature of patients will be measured at intervals of 30 minutes for 6 hours, according to the time in hours since the change from the point of hypothalamic thermostat setting. Tympanic thermometer will be used to measure body temperature.
Primary Outcome(s)
Verify the effectiveness of the use of compress associated with antipyretic for the treatment of adult patients admitted to intensive care unit with a fever. The compresses are applied to the axillary and inguinal regions. The patient's temperature is measured every 10 minutes for a period of 4 hours, this period will also be observed the time that the patient's body temperature took to reach the smaller value 38.3C.
Secondary Outcome(s)
Verify the effectiveness of using a warm compress associated with antipyretic for the treatment of adult patients admitted to intensive care unit with a fever.
The measurements and parameters used to assess this outcome is the same as described for the primary outcome.
Verify the effectiveness of using cold compress associated with antipyretic for the treatment of adult patients admitted to intensive care unit with a fever. The measurements and parameters used to assess this outcome is the same as described for the primary outcome.
Secondary ID(s)
0380.0.203.216-11
Source(s) of Monetary Support
Conselho Nacional de Desenvolvimento Científico e Tecnológico - Belo Horizonte, MG, Brazil
Secondary Sponsor(s)
Hospital Municipal Odilon Behrens - Belo Horizonte, MG, Brazil
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